Identity
- Trade Name
- DIASORIN ETI-AB-AUK PLUS ASSAY FDA PMA
Identifiers
- PMA Number
- P990042 FDA PMA
Classification
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
The ETI-AB-AUK Plus Assay is an in vitro enzyme immunoassay (EIA) designed for the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBS) in human serum or plasma (collected with EDTA, citrate, or heparin). This assay aids in the laboratory diagnosis of seroconversion following hepatitis B virus (HBV) infection and evaluates past exposure or immune response in potential vaccine recipients.
Intended for manual use only, the assay is supplied as a diagnostic tool for clinical laboratories. It is not approved for monitoring HBV disease or therapy. The device requires no special storage conditions beyond standard laboratory practices and is regulated under FDA Premarket Approval (PMA) with PMA number P990042.
Frequently asked questions
What is the ETI-AB-AUK Plus Assay used for in clinical practice?
The ETI-AB-AUK Plus Assay is an in vitro enzyme immunoassay (EIA) specifically designed to qualitatively detect antibodies to hepatitis B surface antigen (anti-HBS) in human serum or plasma. It helps determine seroconversion after hepatitis B virus (HBV) infection and assesses past exposure or immune response in potential vaccine recipients, aiding in laboratory diagnosis for these purposes.
Can this assay be used to monitor HBV disease progression or treatment effectiveness?
No, the ETI-AB-AUK Plus Assay is not intended for monitoring HBV disease progression or evaluating the effectiveness of therapy. Its use is strictly limited to qualitative detection of anti-HBS for diagnosing seroconversion post-infection or assessing immune response in vaccine recipients.
What types of blood samples can be tested with this assay, and how is it supplied?
The assay is designed for use with human serum or plasma collected using EDTA, citrate, or heparin. It is supplied as a manual-use diagnostic tool for clinical laboratories, meaning it requires hands-on processing without automation.
Are there any special storage requirements for the ETI-AB-AUK Plus Assay?
No special storage conditions are required beyond standard laboratory practices. The assay can be stored under typical clinical laboratory conditions, ensuring its stability and usability.
How is the regulatory status of this assay determined, and what does that mean for its use?
The ETI-AB-AUK Plus Assay holds FDA Premarket Approval (PMA) with PMA number P990042, meaning it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended uses. This approval confirms its compliance with regulatory standards for qualitative detection of anti-HBS in serum or plasma, but it does not extend to uses outside its labeled indications, such as monitoring HBV disease or therapy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990042 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P990042 24 fields · synced Sep 18, 2026